focus /
Drug Safety. Whose Responsibility?
When a medicine is marketed, much is known about its quality and pharmacology and in its efficacy in a carefully screened group of patients in clinical trials. These data, however, may provide an incomplete and even misleading account of the drug’s effectiveness in the community at large. Even less is known at the time of marketing approval about its safety in the general population, because of the size of the clinical trials and the selected nature of the subjects included. In other words, its overall benefit-risk balance is uncertain.
Inglese